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Catalog Number 472.412S |
Device Problem
Break (1069)
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Patient Problems
Non-union Bone Fracture (2369); Impaired Healing (2378); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.
Device is not distributed in the united states, but is similar to device marketed in the usa.
(b)(4).
The investigation could not be completed; no conclusion could be drawn, as no product was received.
Based on the information available, it has been determined that no corrective and/or preventative action is proposed.
This complaint will be accounted for and monitored via post market surveillance activities.
If additional information is made available, the investigation will be updated as applicable.
Device was used for treatment, not diagnosis.
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that a valgus malalignment and a not fully healed femur fracture were diagnosed through x-ray images.
A revision surgery was performed on (b)(6) 2020 to correct the valgus malalignment.
During the revision it was noticed that the proximal femoral nail antirotation (pfna) nail was broken.
The pfna was revised.
No further information provided.
Concomitant devices reported: pfna blade perf l90 tan (part 04.
027.
033s, lot 50p9419, quantity 1); lockscr ø5 l36 f/nails tan light green (part 04.
005.
526s, lot 5l66048, quantity 1); lockscr ø5 l38 f/nails tan light green (part 04.
005.
528s, lot 6l89022, quantity 1).
This report is for one (1) pfna ø9 long r 130° l340 tan.
This is report 3 of 4 for (b)(4).
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Search Alerts/Recalls
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